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The 2nd half of Nobel Laureate David Baltimore's Phase I stem cell clinical trial has been approved, sez the below article. In that trial, more patients will now get stem cells with the same protective mutation as that of The Berlin Patient, the only cured HIV patient.

Apparently the second group will also get a conditioning regimen to hopefully increase the percentage of t-cells that are modified.

Calimmune Approved to Treat Second Group in HIV Stem Cell Gene Modification Study

June 25, 2014

San Diego, CA – Calimmune today announced encouraging safety data from its innovative gene-based stem cell therapy, Cal-1-being developed to help cure individuals infected with HIV. The company can now begin treating the second group of patients in the trial, which is being funded in part by a grant from the California Institute for Regenerative Medicine (CIRM).

The company was given the green light to move ahead following a review of safety data by the Data Safety Monitoring Board (DSMB). The DSMB found none of the participants experienced any serious adverse events or dangerous side effects from the therapy.

"We are very excited and encouraged by this development," says Louis Breton, Chief Executive Officer of Calimmune. “This recommendation from the DSMB is an important step in bringing this potential one-time therapy to the patients, and takes us closer to our ultimate goal of eradicating AIDS."

Breton continued: "We are proud of our ongoing partnership with CIRM and are most appreciative of their continued financial support of this critical effort."

The Phase I/II clinical trial focuses on a protein called CCR5 that plays a key role in enabling HIV to infect cells. Blocking CCR5 may provide the cells a protective shield against HIV, which in turn would help retain immune system functionality.

"The mission of CIRM is to efficiently accelerate the development of stem cell treatments for patients suffering from unmet medical conditions," says C. Randal Mills, Ph.D., President and CEO of CIRM. "While still early in clinical development, this announcement demonstrates real progress towards this mission. The accomplishment of Calimmune's team is a great example of how CIRM partnerships are working to impact patient's lives today."

In the first phase of this study 4 HIV-positive participants were infused with their own blood stem cells as well as mature T cells that had been modified to carry a gene that blocks production of CCR5. The hope is that those stem cells will then create a new blood system that is resistant to HIV.

The participants had all previously been on anti-retroviral drugs but had discontinued taking them because of side effects or treatment fatigue, where the body stops responding to the medications as effectively as in the past.

The second group of 3-4 participants will not only get Cal-1 but will also receive a preconditioning regimen, aimed to make the therapy more effective.

The goal of the trial—which is being conducted in San Francisco and Los Angeles—is to assess the safety of the therapy, to determine the ease of use and feasibility of the approach for HIV/AIDS patients and to evaluate what, if any, side effects there may be.

"With more than one million Americans living with HIV/AIDS there is clearly an urgent need for treatments that do more than just hold the virus at bay," says Jonathan Thomas, Ph.D., J.D., and Chair of the stem cell agency’s governing Board. "Current medications are often effective, but come with a big cost both in terms of dollars and side effects. Our goal with this project is to help find an approach that effectively cures people with HIV/AIDS.

About CIRMCIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for Stem cell research, research facilities, and other vital research.

About CalimmuneCalimmune is a clinical-stage HIV gene medicine company focused on developing innovative cell-based therapies for HIV. The company's stem cell technology was discovered in the labs of Nobel Laureate, Dr. David Baltimore (Caltech) and Dr. Irvin Chen (UCLA AIDS Institute). Calimmune is also developing a rich product candidate pipeline to address the needs of different types of individuals at different states of HIV infection and with different levels of treatment experience.

The 2nd half of Nobel Laureate David Baltimore's Phase I stem cell clinical trial has been approved, sez the below article. In that trial, more patients will now get stem cells with the same protective mutation as that of The Berlin Patient, the only cured HIV patient.

The problem has been delivery but in silica modelling has shown that with Calimmune's approach a relatively low level of stem cell engraftment will, overtime, cause substantial reductions in the viral load.

The problem has been delivery but in silica modelling has shown that with Calimmune's approach a relatively low level of stem cell engraftment will, overtime, cause substantial reductions in the viral load.

There is not enough data currently available to support this statement. Until the data from that current trial is published, we simply won't know how effective CAL-1 will be.

The mathematical model is interesting but it does not model the combined treatment of the CD4+ T cells and the CD34+ hematopoietic stem cells, which is the basis of the current trial. Furthermore, we still do not know what the transfection rates for the three arms of the trial will be.

Until we know how these parameters influence the treatment, any assumptions will be premature.

Thanks, all, for the info on this thread. I'm trying to moderate the time I spend on reading about potential cures (see recent complementary thread in this topic area "cure--discussion"), in order to work on "acceptance" of my positive status, but I can't help but be excited about some of the current research out there. I hope some of these things pan out, individually or in concert, to forge the next great advancement in treatment, if not cure.

I will keep an eye out, dico, for the Louis Picker talk this week and will send it on here, if others don't do so first. I think it's supposed to be a talk before a local Chamber of Commerce or something like that (I think I read that in one of the forums here).

In the meantime (of course, all of us can Google things), I stumbled on this handy link that is relatively recent and shares a collection of ongoing research studies. I'm passing it on for everyone's convenience: